Resources

Guides for lab and quality leaders

Practical, vendor-neutral guidance on selecting, validating and getting value from laboratory informatics.

21 CFR Part 11 Checklist for LIMS: What Your System Must Do

A practical 21 CFR Part 11 checklist for LIMS: scope, closed vs. open systems, every Subpart B and C control, and what to verify in your system.

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Featured · Guide 11 min read

LIMS Buyer's Guide 2026: How to Evaluate and Select a Laboratory Information Management System

A vendor-neutral guide to choosing a LIMS in 2026: requirements, deployment models, validation, integration, total cost of ownership and a scoring matrix.

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Compliance 11 min read

21 CFR Part 11 Checklist for LIMS: What Your System Must Do

A practical 21 CFR Part 11 checklist for LIMS: scope, closed vs. open systems, every Subpart B and C control, and what to verify in your system.

Read article

Guide 11 min read

LIMS Buyer's Guide 2026: How to Evaluate and Select a Laboratory Information Management System

A vendor-neutral guide to choosing a LIMS in 2026: requirements, deployment models, validation, integration, total cost of ownership and a scoring matrix.

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Compliance 8 min read

Data Integrity and ALCOA+ in the QC Laboratory

What ALCOA and ALCOA+ mean for QC lab records, the data integrity failures inspectors cite most, and how system design and audit trail review prevent them.

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Best practice 9 min read

From CSV to CSA: Validating Lab Software the Risk-Based Way

How lab software validation is moving from document-heavy CSV to risk-based assurance, what GAMP 5 and FDA's CSA guidance mean, and how to validate a SaaS LIMS.

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Compliance 10 min read

ISO/IEC 17025:2017 and Your LIMS: Clause-by-Clause Requirements

How ISO/IEC 17025:2017 clauses on competence, equipment, methods, records, uncertainty, reporting and data control translate into LIMS capabilities.

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Explainer 8 min read

LIMS vs. ELN vs. LES vs. SDMS: What Each System Does and When You Need It

What LIMS, ELN, LES and SDMS each do, how they differ and overlap, why unified lab platforms are replacing point solutions, and how to decide what you need.

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Best practice 10 min read

Replacing a Legacy LIMS: A Step-by-Step Migration Playbook

A phase-by-phase playbook for replacing a legacy LIMS: assessment, data cleansing, migrate-or-archive decisions, master data mapping, validation and cutover.

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